A randomised double blind study comparing dexmedetomidine with dexamethasone as an adjunct to ropivacaine in ultrasound guided interscalene block for shoulder surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- duration of post-operative analgesia as measured ( in minutes ) by the time from the achievement of adequate sensory block till the first use of fentanyl bolus by PCA
研究概览
简要总结
This study is a randomised ,double blind, single centre trial comparing the efficacy of dexamethasone and dexmedetomidine for post operative analgesia and cumulative total analgesic consumption when administered under ultrasound guidance as an adjunct to ropivacaine in interscalene block.it will be done in a period of 2 years in ASA 1 patients. pain will be assessed on basis of VAS score. Two groups will be studied , group 1 using .5 % ropivacaine 20 ml containing dexamethasone ( 8 mg ) to a total of 22 ml. group 2 using .5 % ropivacaine 20 ml with 2 ml of saline containg dexmedetomidine .5 mcg/kg to a total of 22 ml. Primary outcome will see the duration of postoperative analgsia, in minutes by the time from the achievement of adequate sensory block till the first use of fentanyl bolus by PCA. Secondary outcome will measure pain ratings over 24 hour on 0-100 VAS ,total postoperative analgesic consumption ,patient satisfaction and adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA status 1-2
- •18-30 kg/m2
- •Shoulder surgery such as rotator cuff repair, recurrent shoulder dislocations, acromioplasty, hemiarthroplasty and total shoulder replacement.
排除标准
- •patient refusing to give informed consent
- •history of relevant drug allergy
- •history of psychiatric illness, substance abuse
- •severe cardiovascular, respiratory, metabolic or neurologic disease
- •pregnancy and lactation
- •coagulopathy
- •contralateral phrenic nerve dysfunction
- •infection at planned injection site 9.patients receiving alpha 2 agonists for hypertensive disorders 10.patients on steroids.
结局指标
主要结局
duration of post-operative analgesia as measured ( in minutes ) by the time from the achievement of adequate sensory block till the first use of fentanyl bolus by PCA
时间窗: o hour- time at which adequate sensory block is achieved | To time till the patient takes first dose of rescue analgesic( in 24 hours )
次要结局
- pain ratings over 24 hours on 0-100 VAS , total post-operative analgesic consumption, patient satisfaction and adverse effects.(2 hourly monitoring after 4 hours of nerve block upto 24 hours .)